Gainers & Losers Of Aug.14: TTOO, TBPH, SGMO, APEN, ZYNE...

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of August 14, 2017.

GAINERS

1. T2 Biosystems Inc. (TTOO)

Gained 19.57% to close Monday's (Aug.14) trading at $3.91.

News: No news

Recent event:

On August 3, 2017, the Company reported financial results for the second quarter ended June 30, 2017.

Net loss attributable to common shareholders for the recent second quarter was $15.5 million or $0.50 per share compared to a net loss of $14.0 million or $0.58 per share in the same period prior year. Product revenue for Q2, 2017 rose to $735 thousand from $151 thousand in the year-ago quarter.

The Company has two FDA-cleared products - T2Candida and T2Dx for the detection of sepsis-causing pathogens directly from a whole blood specimen in approximately 4 hours. T2Candida and T2Dx were greenlighted by the FDA in September 2014. The two products received CE marking in July 2014.

In July of this year, the Company's another diagnostic application T2Bacteria Panel received the CE marking, allowing for the commercialization of the product in Europe. A European hospital could begin testing patients with T2Bacteria Panel for clinical purposes later this year.

The Company expects to file with the FDA seeking market clearance for T2Bacteria Panel shortly. If all goes well as planned, T2Bacteria Panel will receive thumbs up from the FDA by the end of 2017.

TTOO was trading around $2.96 when we alerted our premium subscribers to the stock on August 8, 2017.

2. Dova Pharmaceuticals Inc. (DOVA)

Gained 19.51% to close Monday's trading at $21.81.

News: No news

Recent events:

On August 10, 2017, the Company reported Q2, 2017 financial results.

Net loss for the second quarter of 2017 was $5.5 million or $0.32 per share compared to a net loss of $7.3 million or $0.42 per share for the same period in 2016.

The Company made its trading debut on the NASDAQ Global Market on June 29, 2017 at an opening price of $19.25, about 13% higher than the IPO price of $17.

Pipeline:

The Company's lead product candidate is Avatrombopag for the treatment for thrombocytopenia in patients with chronic liver disease (CLD). The compound was tested in two pivotal clinical trials, ADAPT 1 and ADAPT 2, in which all primary and secondary endpoints were met with high statistical significance.

Near-term catalyst:

The Company expects to file an NDA for Avatrombopag in the third quarter of 2017.

3. Marinus Pharmaceuticals Inc. (MRNS)

Gained 16.94% to close Monday's trading at $2.83.

News: No news

Near-term catalysts:

-- Top-line data from phase II trial of Ganaxolone in children with CDKL5 genetic disorder are expected to be reported in the second half of this year. -- A phase II study of Ganaxolone IV in women diagnosed with severe postpartum depression, dubbed Magnolia study, is underway - with data expected in the second half of this year. -- A phase II study of Ganaxolone capsules in women with moderate postpartum depression, dubbed Amaryllis Study, is expected to be initiated later this year. -- A phase II study of Ganaxolone in patients with Status Epilepticus is also planned for initiation later this year.

4. Theravance Biopharma Inc. (TBPH)

Gained 14.02% to close Monday's trading at $27.48.

News: No news

Recent event:

On August 8, 2017, the Company reported encouraging data from the first cohort of patients in its ongoing Phase 1b clinical trial of TD-1473 in moderate to severe active ulcerative colitis.

Near-term catalysts:

-- The New Drug Application for Revefenacin for the treatment of chronic obstructive pulmonary disease (COPD) is expected to be filed in the fourth quarter of this year. -- A phase IIIb study comparing once daily nebulized Revefenacin with Spiriva once daily delivered via the HandiHaler on lung function in subjects with COPD and a Low Peak Inspiratory Flow Rate is expected to be completed in the first quarter of 2018. -- A phase III study of Closed Triple (the triple combination therapy of fluticasone furoate, umeclidinium, and vilanterol in a single ELLIPTA inhaler) in COPD patients is underway, with results expected this year. -- A phase III study of the Closed Triple in patients with asthma, dubbed CAPTAIN, is scheduled for completion in 2018. -- Data from remaining cohorts of Phase 1b study of TD-1473 in patients with ulcerative colitis are expected to be released in 2018 and data from Phase 2a study of TD-9855 in patients with neurogenic orthostatic hypotension are slated for release in first half of 2018.

5. Sangamo Therapeutics Inc. (SGMO)

Gained 13.17% to close Monday's trading at $11.60.

News: No news

Upcoming event:

The Company is slated to make a presentation at the 2017 Wedbush PacGrow Healthcare Conference on Tuesday, August 15th at 9:45 a.m. Eastern Time.

6. Protagonist Therapeutics Inc. (PTGX)

Gained 12.52% to close Monday's trading at $12.49.

News: No news

Near-term catalysts:

-- Interim analysis of phase 2b trial of PTG-100 in ulcerative colitis patients is expected in early 2018 - with top-line results anticipated for the second half of 2018. -- Results from a phase 1 clinical study of PTG-300 in normal healthy volunteers are anticipated in the second half of 2017. PTG-300 is being developed as a potential treatment for patients with chronic iron overload in rare diseases such as beta-thalassemia.

7. Vascular Biogenics Ltd. (VBLT)

Gained 12.05% to close Monday's trading at $4.65.

News: The Company reported Q2, 2017 financial results and provided a corporate update.

Net loss for Q2, 2017 is $4.9 million or $0.18 per share compared to a net loss of $3.3 million or $0.14 per share in the year-ago quarter.

The Company ended June 30, 2017 with cash, cash equivalents and short-term bank deposits totaling $33.8 million and working capital of $31.8 million.

Near-term catalysts:

-- The Company expects a final DSMC (Data and Safety Monitoring Committee) review of the GLOBE trial to occur in late September.

GLOBE is a pivotal, phase III study comparing Vascular Biogenics' drug candidate VB-111 plus Avastin to Avastin alone in adult patients with recurrent Glioblastoma.

-- The top-line results from the GLOBE trial are expected in Q1, 2018.

8. Zogenix Inc. (ZGNX)

Gained 9.76% to close Monday's trading at $11.25.

News: No news

Near-term catalysts:

-- The top-line data from Study 1 of phase III program of ZX008 in Dravet Syndrome are expected in the third quarter of 2017. The phase III program consists of two studies 1501 and 1502. The results from the combined patient population of studies 1501 and 1502 would be reported as "Study 1". -- Enrollment of second pivotal phase III of ZX008 in Dravet Syndrome, dubbed Study 1504, is now approximately two-thirds complete. Enrollment in this study is expected to be completed in the third quarter of 2017.

LOSERS

1. KemPharm Inc. (KMPH)

Lost 14.06% to close Monday's trading at $2.75.

News: No news

Near-term catalysts:

-- Initiate development of KP484, a new super-extended release (SER) d-MPH being designed for the treatment of ADHD, and file an Investigational New Drug application for KP484 as early as the third quarter of 2017. -- Initiate pivotal efficacy trial of KP415 for the treatment of ADHD in the second half of this year. -- Human clinical trials of KP201/IR for the short-term treatment of acute pain are anticipated to commence in 1H 2017 - with final intranasal human abuse liability (HAL) study data expected in the second half of this year. -- NDA submission for KP415 for the treatment of ADHD is planned for 2018.

2. Apollo Endosurgery Inc. (APEN)

Lost 11.53% to close Monday's trading at $3.99.

The Company deals with less invasive medical devices for bariatric and gastrointestinal procedures.

News: On August 10, 2017, the FDA alerted alert health care providers of five reports of unanticipated deaths that occurred from 2016 to present in patients with liquid-filled intragastric balloon systems used to treat obesity.

Four reports involve the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery.

The following are the clarifications provided by the Company today pertaining to the FDA's alert.

ORBERA, which assists adult patients suffering from obesity with a body mass index of 30 to 40 in losing and maintaining weight, was approved by the FDA in August of 2015. Since its approval, there have been 5 reported deaths of patients who had received the ORBERA intragastric balloon in four different countries, and they were all self reported by the Company. The incident rate remains less than 0.01% and there have been no product liability-related claims in connection with the five cases.

3. Zynerba Pharmaceuticals Inc. (ZYNE)

Lost 8.68% to close Monday's trading at $6.42.

News: The Company's phase II study of ZYN002 CBD gel for the treatment of osteoarthritis, dubbed STOP, did not meet its primary endpoint.

The primary endpoint was reduction from baseline in the weekly mean of the 24-hour average worst pain score at week 12, which was not met. However, statistically significant results were achieved for a number of secondary endpoints.

4. Xenon Pharmaceuticals Inc. (XENE)

Lost 7.41% to close Monday's trading at $2.50.

News: No news

Near-term catalysts:

-- Filing of an investigational new drug application to initiate a Phase 1 first-in-man clinical trial of XEN1101 for the treatment of epilepsy is expected in the fourth quarter of 2017. -- Filing of an investigational new drug application for XEN901 for the treatment of rare infantile epileptic encephalopathies and other forms of epilepsy is also slated for the fourth quarter of 2017.

5. Progenics Pharmaceuticals, Inc. (PGNX)

Lost 6.22% to close Monday's trading at $5.28.

News: No news

Near-term catalyst:

-- The New Drug Application for AZEDRA for the treatment of rare and difficult-to-treat neuroendocrine tumors, pheochromocytoma and paraganglioma is expected to be submitted to the FDA in August 2017.

6. Bellicum Pharmaceuticals Inc. (BLCM)

Lost 5.53% to close Monday's trading at $7.52.

News: No news

Pipeline:

The company's lead product candidate is BPX-501, which is being evaluated in multiple phase 1/2 clinical trials in adults and pediatric patients with leukemias, lymphomas, and genetic blood diseases in the U.S. and Europe.

Near-term catalysts:

-- Enrollment in a Phase 1/2 clinical trial of BPX-501 in children with leukemias, lymphomas, or orphan inherited blood disorders, for which HSCT (hematopoietic stem cell transplantation) is curative, dubbed EU BP-004, remains on track for completion by the end of 2017. -- An observational trial in pediatric patients receiving transplants from matched unrelated donors (MUD) without BPX-501 is expected to be initiated in the third quarter of 2017. -- The top-line results from the above two studies are expected in the second half of 2018, with MAA filing planned for 2019.